Phase II Trial of AVAC™ in Childhood Eczema

Genesis Research and
Development Corporation (NZX/ASX: GEN) and its partner,
London-based biopharmaceutical company SR Pharma (LSE: SPA)
today announced the commencement of a randomised,
placebo-controlled Phase II trial of AVAC™ in paediatric
atopic dermatitis (childhood eczema).

This trial, which
will involve 120 children aged from 5 to 16 years, will be
conducted in Auckland. Each participating child will be
randomly allocated to one of two treatment groups, and will
receive three injections of either AVAC or placebo, at
intervals of two weeks. The trial will assess both the
efficacy and safety of AVAC treatment. Quality of life data
will also be collected.

The New Zealand AVAC trial
complements the Phase II trial of SRP299™ (a heat-killed
Mycobacterium vaccae suspension) in childhood eczema, which
is currently underway in the United Kingdom. SR Pharma and
Genesis Research are jointly developing SRP299 and AVAC for
the treatment of atopic dermatitis. The results of both the
New Zealand and the UK Phase II trials are expected to be
available at the end of 2004.

“This new AVAC Phase II
trial follows on from our recent successful Phase I safety
trial in children,” says Genesis CEO, Dr Jim Watson. In that
trial, clinical improvement in atopic dermatitis was noted
in the majority of the children as measured by a standard
scoring system for eczema. “The Phase II trial will allow us
to accurately assess the benefits resulting from AVAC
treatment of children with eczema.”

About atopic
diseasesAtopic diseases comprise atopic dermatitis,
asthma and allergic rhinitis. An atopic individual is likely
to experience symptoms of one or more of these conditions
from an early age and this may persist for lengthy periods
during their lifetime.

Importantly, the prevalence of
atopic disease in the western world has tripled over the
past 30 years. It has been postulated that this increase in
prevalence is causally related to a marked reduction in the
incidence of infectious diseases experienced in these
communities over that period.

Atopic dermatitis is
estimated to affect 10–20 percent of children at some point
during childhood and represents the commonest inflammatory
skin disease of childhood. Sixty million people suffer from
atopic dermatitis in Europe and the USA. The prevalence in
seven year olds was recently reported as 16 percent in
Northern Europe and 22.7 percent in Singapore.

About
Genesis Founded in 1994, Genesis is a New Zealand based
biotechnology company with 140 staff. It is committed to the
building of a broad genomic platform for the development of
innovative products in health and plant biotechnology.
Genesis partners with industry leaders to develop products
that have global market potential through the mining of its
extensive microbe, plant and mammalian EST databases.

The
Health Division focuses on the immune system and has two
programmes in human clinical development for the treatment
of psoriasis and atopic dermatitis (eczema), with additional
programmes for cancer and other indications in pre-clinical
development. The patented BioStore solutions for storage of
tissues and living cells are also in pre-clinical
development. Collaborations are maintained with Amgen Inc.
(Nasdaq: AMGN), Corixa Corporation (Nasdaq: CRXA), SR Pharma
(LSE: SPA), Jurox Pty Ltd, and EvoGenix Pty Ltd.

The Plant
Sciences division is focusing on key cell signalling genes –
novel hormones and transcription factors - to control
commercial traits including growth rates and wood fibre
quality in trees, nutritional content of forage grasses,
flowering control and stress tolerance. It has research
collaborations with ArborGen, LLC, Wrightson Ltd (NZX: WRI),
HortResearch, AgResearch and Landcare. Genesis is also
undertaking significant unpartnered research programmes in
novel plant hormones.

The company has an extensive health
and plant patent portfolio.

For more information, please
visit www.genesis.co.nz

About SR PharmaSR Pharma plc
was founded in 1992 and is committed to developing
innovative medicines based on an improved understanding of
the role played by the immune system in combating disease.

The company’s proprietary M. vaccae-based technology is
the source of a number of product developments. SRP299 is
currently being evaluated for the treatment of asthma and
atopic dermatitis. The company is also investigating SRL172™
as both a monotherapy and as a vaccine adjuvant in cancer
and infectious diseases. These products enhance the immune
responses needed to combat cancer and infection, while
regulating those that mediate allergies. Additional
information can be found on the company’s website at
www.srpharma.com

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